In responding to an new report recommending that psilocybin (the active ingredient in magic mushrooms) should be moved from Schedule 1 to Schedule 2 of the Misuse of Drugs Regulations (2001) to facilitate medical research & development, the Home Office spokesperson said the current classification of psilocybin under Schedule 1 does not prevent research or clinical trials.
The report, ‘Medicinal Use of Psilocybin: Reducing restrictions on research and treatment’, was written by six leading doctors and experts and was produced by the Conservative Drug Policy Reform Group (CDPRG) and the Adam Smith Institute (ASI). It finds that the Schedule 1 status of psilocybin makes research into its therapeutic potential extremely difficult to conduct.
To support important research without increasing the likelihood of recreational use, the authors propose rescheduling psilocybin on a research-only basis, finding no evidence that this would risk an increase in illicit use, related harms, or criminal activity. The rescheduling would, however, dramatically reduce the obstacles to legitimate scientific and medical research.
In response to the report, which was publicly released on Monday 27 July 2020, the Home Office told The Guardian:
“We need to strike the right balance between enabling legitimate research to take place in a secure environment while ensuring that harmful drugs are not misused and do not get into the hands of criminals. The current classification of psilocybin under Schedule 1 does not prevent research or clinical trials under a Home Office licence.”
This comment does not address the salient findings of the report, Crispin Blunt MP, points out. While, theoretically, Schedule 1 regulations do not preclude research, in practice, the associated costs and delays are so significant that they deter many researchers from working with those drugs and substantially complicate the studies that do take place.
The Home Office is correct that it is possible to conduct research into psilocybin under Schedule 1, but the response bypasses the great extent to which Schedule 1 regulations pose obstructions to potential and ongoing research in terms of costs and timeframes. Neither does the Home Office’s response address the report’s detailed exploration of the economic and social burden of mental illness in the UK, nor its discussion of the untapped potential of psilocybin assisted treatment.
In addition to the scale of suffering and the social burden, depression costs the UK economy an estimated £10bn per year in reduced productivity, missed work, and treatment costs, with mental illness as a whole costing up to £94bn. Almost no new drugs have been approved for depression in decades, but psilocybin therapies are now being investigated in clinical trials.
The evidence so far suggests that psilocybin may be a valuable new treatment option, particularly for people for whom other antidepressants have not worked.
Dr. Johnny Martell, Clinical Research Fellow at Imperial College London, is one of the doctors who orchestrated the Imperial College Psychedelic Research Centre’s most recent double-blind, placebo controlled trial, comparing the effects of psilocybin versus traditional SSRI antidepressant escitalopram for 60 patients with moderate to severe depression.
Martell says, “As an NHS psychiatrist working on the recent Imperial College psilocybin trial, I have witnessed the enormous promise this treatment has for patients with depression. That psilocybin research continues to be hamstrung by a scheduling that ignores both science and social history is not only an appalling injustice to patients, but, of likely greater interest to government, a potentially catastrophic own-goal, given depression's enormous impact on the nation's economic health. The government simply must act on this report's recommendations.”
A growing body of clinical and experimental research also indicates that psilocybin may be effective in treating substance misuse disorders such as nicotine addiction, end-of-life anxiety in patients with terminal cancer, and post-traumatic stress disorder (PTSD).
The report illuminated the severity and consequences of the UK's mental health crisis, underscoring the need for research into psilocybin, which is uniquely significant for its potential to mitigate it. The ethical necessity of an urgent rescheduling of psilocybin, highlighted in the report, appears to have been ignored in the response from the Home Office.
Blunt, unremunerated Chair of the Conservative Drug Policy Reform Group LTD and MP for Reigate, says:
“The Home Office response is contradicted by half a century of evidence, which makes it clear that to date they have struck the wrong balance. We can find not a single example in the history of the current drug law framework where a drug listed under Schedule 2 has found its way out of clinical trials and into the hands of criminals. The risks with psilocybin therapies are even lower because the drug is not given to patients to take home. In other words, there is no evidence of any benefit given the objective of Home Office policy of this drug being Schedule 1 as opposed to 2. But the costs are probably enormous.
“We will now commission research into identifying just how much economic damage has been done by this state of affairs, in relation to the expenses around research. The damage that has been done to the mental health of the nation by this over-regulation, however, is incalculable - but since it has been cumulative over half a century, it is highly likely that this too is highly economically significant.”
Jeff Smith MP, founder of the Labour Campaign for Drug Policy Reform, also addresses the misfocus of the Home Office’s initial response, “While technically possible, it is extremely slow, difficult and expensive to attempt medical research into psilocybin while it remains in schedule 1. Despite what the Home Office may claim, this scheduling is undeniably a huge barrier to research, as evidenced by how few studies have been able to take place over the last 50 years.”
Smith, who is co-Chair of APPG for Drug Policy Reform and Chair of the APPG on Mental Health, continues, “It just doesn’t make sense to classify psilocybin in this way. I’ve heard powerful testimony and emerging evidence about how psychedelic medicine can help with a range of health issues, particularly acute mental health issues. I’m convinced that there is real potential to use these drugs for good, and that they could help a significant number of people who are currently suffering. The Home Office must rethink its position and take steps to allow this research to happen unhindered, so that we can better understand and build on the evidence.”
Both Smith and Blunt are members of the DrugScience Medical Psychedelics Working Group, co-chaired by Jo Neill, Professor of Psychopharmacology at Manchester University and Prof. David Nutt, Edmond J. Safra Professor of Neuropsychopharmacology and director of the Neuropsychopharmacology Unit in the Division of
Brain Sciences at Imperial College London. The Working Group met this week on Thursday 30 July to strategise the enactment of changes to legislation to better enable clinical research into the therapeutic potential of psychedelics.
On the Home Office’s response to the recommendations in Medicinal Use of Psilocybin, Neill says, “Let’s be very clear that it is true that it is technically possible to do this research, but getting a controlled drugs licence is bureaucratic, delays of six months to a year are standard, the costs are prohibitive for many researchers - for many laboratories it is simply too much, starting at between £3,000 and £20,000.”
Speaking at the DrugScience Working Group yesterday on the unnecessary challenges posed to clinicians by the Schedule 1 status, Nutt said, “we managed to get a grant to study treatment-resistant depression and psilocybin from the Research Council based on the fact that depression is an enormous problem. It took 13 months to get the drugs supplied because of the bureaucratic burden of Schedule 1 drugs, and all in all it cost £1,500 per dose — almost, in fact, totally driven by the fact that this is a Schedule 1 drug. The results were quite remarkable, possibly the most powerful single-intervention impact in depression there’s ever been, half participants were depression-free at one week and about a third were depression-free at three months.”
A peer-reviewed economic analysis of the costs and delays that Schedule 1 classification imposes upon research has been commissioned by the Conservative Drug Policy Reform Group. This new report, planned for publication this Autumn, will quantify the extent of these unjustifiable economic costs, which have the effect of reducing the number of clinical studies being undertaken, the number of trial participants recruited, and the time that a study takes to complete. This dramatically stunts the growth of the UK life sciences sector in this area and slows the development of important new medicines. The analysis will also assess the potential savings that could be achieved by moving psilocybin to Schedule 2, which notably already contains much more dangerous substances than psilocybin and which are at higher risk of diversion, such as fentanyl, heroin and cocaine.
Blunt adds, “The case for this limited but important change is overwhelming. We’re confident it will be addressed at some point, but for every day of delay, someone, or indeed many someones, are hurting somewhere unnecessarily.”
Contact CDPRG Outreach Officer Ros Stone on 08921766060 or [email protected] to be connected to those quoted.
Links
● "Ease restrictions on medical psychedelics to aid research, experts say" (The Guardian)
● "Magic mushrooms should be made legal in the same way as cannabis so they can be used to treat depression, leading doctors say" (The Daily Mail)
● “Home Office chiefs urged to relax ban on magic mushrooms to tackle Covid-19 mental health crisis" (The Sun)
● "Legalise magic mushrooms to treat depression, say leading doctors" (The Telegraph)
● "Government urged to treat research into psychedelic drug to treat depression" (The Independent)
● Sky News: Interview with Prof. Jo Neil, Chair of the Drug Science Medical Psychedelics Working Group, discussing the paramount importance of reducing restrictions to research into psilocybin.
● The Medicinal Use of Psilocybin (press pack and full report)